MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE— 510(k) K990411

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K990411 for MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE, Substantially Equivalent on 1999-05-11. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 1999-02-10
Decision date: 1999-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.